SAFETY INTRODUCER NEEDLE

K030135 · B.Braun Medical, Inc. · DYB · Jul 15, 2003 · Cardiovascular

Device Facts

• Record ID: K030135
• Device Name: SAFETY INTRODUCER NEEDLE
• Applicant: B.Braun Medical, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Jul 15, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Safety Introducer Needle is an anti-needlestick device that provides access to the vascular system for the introduction of a guidewire.

Device Story

Safety Introducer Needle provides vascular access for guidewire introduction. Device consists of standard needle, needle hub, and user-activated safety clip mechanism. Clinician pulls clip puller down needle length to shield needle after use, reducing accidental needlestick risk. Available in 18-21 gauge sizes, 1.5-2.75 inch lengths; optional echogenic tip allows visualization via ultrasound. Color-coded hubs aid gauge identification. Used in clinical settings by healthcare professionals.

Clinical Evidence

Bench testing only.

Technological Characteristics

Needle sizes 18-21G; lengths 1.5-2.75 inches. Features user-activated safety clip mechanism for needle shielding. Optional echogenic tip for ultrasound visualization. Color-coded hubs for gauge identification. Mechanical device; no energy source or software.

Indications for Use

Indicated for vascular access for guidewire introduction. Designed to minimize inadvertent needlesticks during clinical use.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Medamicus Guidewire Introducer Safety Needle (K011085)
• Introcan Safety IV Catheter (K021094)

Submission Summary (Full Text)

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## 7.0 510(k) Summary

| SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341<br>[phone], ext. 2375<br><br>Contact: Amy K. Smith, RA Specialist |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Safety Introducer Needle |
| COMMON OR USUAL<br>NAME: | Guidewire introducer needle |
| DEVICE<br>CLASSIFICATION: | Catheter Introducer, 21 CFR 870.1340, Product Code DYB |
| PREDICATE DEVICE: | Medamicus, Inc.<br>Medamicus Guidewire Introducer Safety Needle, K011085<br>B. Braun Medical Inc.<br>Introcan® SafetyTM IV Catheter, K021094 |
| DESCRIPTION: | The Safety Introducer Needle consists of a standard needle<br>with an user-activated safety mechanism clip, clip puller<br>and needle hub. The Safety Introducer Needle ranges in<br>size from 18 - 21 gauges and has needle lengths between<br>1.5 - 2.75 inches. The needle can be made with an<br>echogenic tip. An echogenic tip allows the tip of the needle<br>to be located using Ultrasound techniques. The needle<br>hubs are color coded to aid in recognition of needle gauge<br>size. The safety clip mechanism reduces the risk of<br>accidental needlestick injuries by shielding the needle. The<br>safety clip mechanism will activate once the puller is pulled<br>down the length of the needle. |
| INTENDED USE: | The Safety Introducer Needle is an anti-needlestick device<br>that provides access to the vascular system for the<br>introduction of a guidewire. |
| SUBSTANTIAL<br>EQUIVALENCE: | The B. Braun Medical Inc. Safety Introducer Needle is<br>similar to the Medamicus Guidewire Introducer Safety<br>Needle (K011085) in indications for use and other |

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application features such as needle size and guidewire sizes accepted. The Safety Introducer Needle is substantially equivalent to the Introcan Safety IV Catheter in materials and function of the safety clip mechanism.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 15 2003

B. Braun Medical, Inc. c/o Ms. Amy K. Smith 901 Marcon Blvd. Allentown, PA 18109

Re: K030135 Safety Introducer Needle Regulation Number: 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: May 1, 2003 Received: May 5, 2002

Dear Ms. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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## Page 2 - Ms. Amy K. Smith

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

OleTM

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Correspondence to Mr. Shang Hwang Pending 510(k) K030135 05/01/03 Page 28 of 37

## Indications for Use Statement

Page __________ of ___________________________________________________________________________________________________________________________________________________________

1030135 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Safety Introducer Needle Device Name:

Indications For Use:

The Safety Introducer Needle incorporates an active safety clip mechanism designed to minimize inadvertent needlesticks when the needle is used to introduce a guidewire.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

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OR

Over-The-Counter Use

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